Green Cross Tenofovir Disoproxil Fumarate Tablet

Adult dose

Adults For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet (300 mg) once daily. It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. 2. Patients with renal impairment Drug exposure was significantly increased when this medicine was administered to patients with moderate to severe renal impairment. Therefore, for patients with a baseline creatinine clearance of <50mL/min, adjust the dosing interval according to Table 1. These dosing interval adjustment recommendations are based on pharmacokinetic data modeling of a single dose in patients with various degrees of renal impairment who are not infected with HIV or HBV, including patients with end-stage renal disease requiring hemodialysis. The safety and efficacy of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment; therefore, renal function and clinical response to treatment should be closely monitored in these patients (see Warnings 3). No dosing interval adjustment is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min); monitor calculated creatinine clearance and serum phosphorus regularly (see Warnings 3). Table 1. Dosing interval adjustment according to creatinine clearance Creatinine clearance (mL/min)a ≥50 Recommended interval for 300mg doses Every 24 hours 30-49 Every 48 hours 10-29 Every 72-96 hours Patients on hemodialysis Every 7 days or approximately 12 hours after dialysisb a. Calculated using ideal (lean) body weight. b. Administer once weekly, generally assuming 3 hemodialysis sessions of approximately 4 hours each per week. This medicine should be administered after dialysis is completed. The pharmacokinetics of tenofovir have not been evaluated in patients with creatinine clearance below 10mL/min who are not receiving hemodialysis; therefore, no dosing recommendations are available for these patients.

Child dose

Pediatric patients aged 12 years and older (35kg or more) For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet (300 mg) once daily. It may be taken with or without food. The safety and efficacy of this medicine have not been established in pediatric patients weighing less than 35kg with chronic hepatitis B. There are no data to support dosage recommendations for pediatric patients with renal impairment.

This medication may cause serious liver problems; therefore, individuals such as women, those who are obese, and those who have been on medication for a long time should closely monitor their liver condition. Discontinuing the medication can lead to a sudden worsening of hepatitis symptoms, so liver condition should be monitored for a long time even after stopping treatment. This drug can affect kidney function; therefore, regular kidney function tests should be conducted before and during treatment, and patients with significantly reduced kidney function may need to adjust their dosing schedule. It should not be taken with certain specific medications, and especially patients co-infected with HIV-1 and hepatitis B should use it under a specialized treatment plan. Patients with low bone density or at risk of fractures should regularly check their bone health and may take calcium or vitamin D supplements if necessary. Body fat distribution may change, so changes in the body need to be monitored, and inflammatory responses or autoimmune diseases may appear during the recovery of the immune system, necessitating consultation with a doctor. During the use of this medication, symptoms such as headache, diarrhea, nausea, weakness, and depression may appear, and any severe adverse effects should be reported to medical personnel immediately. Individuals with allergic reactions or lactose intolerance should avoid this drug, and those with a history of allergies should exercise caution. It should be used during pregnancy only when necessary, and nursing mothers should avoid breastfeeding as the drug may be passed to the infant. Safety and efficacy have not been established for children under 12 years old, so it should not be used in this age group. Elderly patients or those with reduced kidney function should use it with caution, and kidney function should be tested frequently. In case of overdose, seek medical attention immediately for appropriate treatment, and dialysis can be used to remove the drug from the body. This medication should be kept out of reach of children and stored in its original container to maintain its quality.

Hepatomegaly accompanied by hyperlactatemia and steatosis, acute renal failure, Fanconi syndrome, rash, diarrhea, headache, pain, depression, asthenia, nausea, dizziness, vomiting, dyspepsia, arthralgia, myalgia, insomnia, peripheral neuropathy, anxiety, pneumonia, fever, abdominal pain, back pain, fatigue, sinusitis, upper respiratory infection, nasopharyngitis, dizziness, fatigue, sweating, weight loss, loss of appetite, abdominal distension, pneumonia, fractures, osteomalacia, muscle weakness, myopathy, acute tubular necrosis, hepatitis, increased liver enzymes, hypokalemia, hypophosphatemia, dyspnea, pancreatitis, increased amylase, rash, rhabdomyolysis, renal failure, hepatic steatosis, nephrogenic diabetes insipidus, proteinuria, polyuria, asthenia, allergic reactions, angioedema, hair loss, erythema multiforme, sialadenitis, paronychia, urticaria, sensory impairment, cerebral infarction, diabetic neuropathy, metabolic encephalopathy, seizures, cholelithiasis, cirrhosis, alcoholic fibrosis, hepatic insufficiency, liver fibrosis, hand fractures, febrile neutropenia, leukopenia, thrombocytopenia, deep vein thrombosis, corneal degeneration, graft-versus-host disease, benign prostatic hyperplasia, sleep disturbances, bladder dysfunction, urolithiasis, dysuria, renal cysts, ureteral calculi, anemia, splenomegaly, thrombocytopenia, decreased appetite, eating disorders, cough, rhinitis, upper respiratory cough syndrome, hypertension, conjunctival hemorrhage, ocular movement disorders, ocular congestion, graft-versus-host disease, benign prostatic hyperplasia

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The recommended storage temperature is between 1°C and 30°C. Doing so will help maintain the drug's efficacy and safety over a long period.

Appearance

Pale blue almond-shaped film-coated tablets

Package unit

30 tablets/bottle